D-Serine Treatment For Tardive Dyskinesia

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Brief Title

D-Serine Treatment For Tardive Dyskinesia

Official Title

D-SERINE TREATMENT FOR TARDIVE DYSKINESIA

Brief Summary

      Presently no generally effective treatments for tardive dyskinesia (TD) are available.
      D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric
      modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous
      studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which
      are caused by treatment with presently used antipsychotics drugs.

      The hypothesis under investigation in the present study is that D-serine adjuvant treatment
      may improve TD in schizophrenia patients diagnosed with this disorder.
    



Study Type

Interventional


Primary Outcome

Change in AIMS total score


Condition

Schizophrenia and Schizoaffective Disorder

Intervention

D-serine

Study Arms / Comparison Groups

 D-serine adjuvant treatment
Description:  Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.
First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

16

Start Date

January 2013

Completion Date

January 2019

Primary Completion Date

January 2019

Eligibility Criteria

        Inclusion Criteria:

          1. age 18-70;

          2. diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria;
             diagnosis will be made on the basis of SCID interview and information from medical
             records, previous treating psychiatrists, and family informants;

          3. history of ≥3 months antipsychotic drugs treatment and present stable dose
             antipsychotic treatment for at last 4 weeks;

          4. fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12
             weeks prior to study entrance and on a subsequent evaluation performed prior to
             allocation to experimental treatment.

        Exclusion Criteria:

          1. meeting criteria for other DSM-IV Axis I diagnoses;

          2. presence of a neurological disorder or history of significant head injury;

          3. substance abuse or alcoholism during entire lifetime;

          4. are judged clinically to be at suicidal or homicidal risk;

          5. female patients who are pregnant or lactating; female patients who are not pregnant or
             lactating, if sexually active, must be using medically accepted means of
             contraception.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Uriel Heresco-Levy, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT01804920

Organization ID

1600


Responsible Party

Principal Investigator

Study Sponsor

Herzog Hospital


Study Sponsor

Uriel Heresco-Levy, MD, Principal Investigator, Herzog Hospital


Verification Date

October 2018